In the News

Essential Formulas' CHIA OMEGA + Vitamin D3 Wins "Best of Supplements Award"

Cure for Alzheimer's Disease?

Women are Comfortable with Non-Hormonal Therapies, but Few Have Discussed with their Doctor

Nurse practitioners are increasingly focused on promoting patient adherence, study finds

Newly-Published Study Concludes Stretta May Be More Desirable GERD Treatment than Chronic PPI Use or Anti-Reflux Surgery in Some Patients

Researchers Discover a New Pathway in Blood Vessel Inflammation and Disease

Cancer Experts Detail New Approaches to Liver Cancer Treatment

Essential Formulas' CHIA OMEGA + Vitamin D3 Wins "Best of Supplements Award"

One of four plant-based Omega-3 formulations recently launched by Essential Formulas Incorporated has been honored for its use of high-protein Chia seed oil combined with key dietary and antioxidant support for optimum health and convenience.

Derived from high-protein Chia seeds documented to offer more ALA Omega-3 than fish or flax seed oil, Chia seed oil is considered to be one of the planet's richest and most sustainable sources of this essential fatty acid (EFA). These revolutionary products not only support a healthy Omega-3-to-6 ratio, but also augment with additional synergetic ingredients for a consumer's individual health goals.

Honored with a "Best of Supplements Award" in the New Supplement category, CHIA OMEGA + Vitamin D3, a certified vegetarian product, is leading the way in combining cold-pressed Chia seed oil with highly bioavailable Vitamin D3. Known to support both bone health and healthy mood, Vitamin D3 is a synergetic addition to Omega-3, known to help support healthy heart function and mental cognition.

"We knew there was a market for a fish oil alternative and are excited to be able to offer a vegetarian Omega-3 option that not only eliminates fishy aftertaste, but is also is believed to be a better Omega-3 overall," said Michael Schoor, CEO and President of EFI.

In its sixth year presenting the "Best of Supplements Award," Better Nutrition Magazine selected the winners from manufacturer nominations, natural health retailer's survey and input from the Better Nutrition's Advisory Board, which consists of naturopathic practitioners, journalists and staff. For more information on all the CHIA OMEGA Formulations visit chiaomega.com.

The award will be presented during Natural Products Expo East, September 26-28 in Baltimore.

Cure for Alzheimer's Disease?

Renowned Inventor and Entrepreneur Eric Knight Unveils Alzheimer's Treatment System in Conjunction with World Alzheimer's Month

Eric Knight, widely known for novel inventions, business innovations, and aerospace endeavors, believes he has invented a method with the potential to treat Alzheimer's disease—a disease that has thwarted the world's leading scientists and medical professionals.

In a press statement issued today, Knight said, "Alzheimer's is one of the most dreadful diseases, cruelly stripping away a person's humanity and ripping apart the fabric of families. A staggering 5.2 million Americans have Alzheimer's disease; it is the sixth-leading cause of death in the US. Compounding the human pain, Alzheimer's disease drains the American economy by over $200 billion per year in healthcare costs. It's an international crisis as well, affecting 35 million people worldwide. This human and economic tragedy must end."

Knight continued, "Three-and-a-half years ago, I began working on an invention that appears to have the potential to remove from the brain the beta-amyloid ‘plaque' associated with Alzheimer's disease. I completed my first prototype in 2010, and continued my research and development to the point where I could patent the device. My therapeutic system applies simple radio waves in a particular method via aerospace-inspired technology. So, in effect, I've applied ‘rocket science' in a new and novel way to create this Alzheimer's treatment technique."

Knight has a broad-ranging patent application pending on his invention to treat Alzheimer's disease.

Knight added, "I believe an invention of this potential magnitude needs to go into clinical trials as rapidly as possible. We need to find out if my invention will indeed show promise and prove clinically viable to the millions of individuals afflicted with Alzheimer's disease. I'm pleased to unveil my invention during World Alzheimer's Month. I'm looking for one or more industry partners with the wherewithal to take the next steps."

Knight concluded, "It's not hyperbole to say this invention, if it proves itself, may be worth hundreds of millions of dollars. But money is not my driving motivation. Far from it. At this stage in my business career, I'm focused on innovations that help people wherever and whenever I can. That's my greatest reward."

Knight's company has established a special phone line to arrange confidential discussions with potential industry partners: (860) 993-1310. There is also a special e-mail address: alzinvention@remarkable.com

Women are Comfortable with Non-Hormonal Therapies, but Few Have Discussed with their Doctor

While more than two-thirds of women ages 50-64 stated they are comfortable with using non-hormonal therapies for menopause-related hot flashes, only 10 percent reported they have talked to their doctor about these options. Additionally, more than half reported they were not aware of all the options available to them.

In the United States, an estimated 50 million women have reached menopause, and most women will spend at least one-third of their lives beyond their final menstrual period. Hot flashes are one of the most common symptoms of menopause, with 65 to 80 percent of women experiencing hot flashes to some degree. Despite the number of women affected by hot flashes, many are not aware of the variety of therapies available to them.

The survey, conducted online by Harris Interactive on behalf of the Society for Women's Health Research (SWHR) and Metagenics in April this year among 314 US women ages 50 to 64, found that while more than half (52 percent) were not aware of non-hormonal options, more than two thirds (69 percent) reported they would be comfortable with using alternative and non-hormonal therapies to help reduce their hot flashes.

"Hot flashes can be very bothersome and disruptive to women, and there is some confusion about the range of available hot flash therapies," said Phyllis Greenberger, MSW, President and CEO of SWHR. "SWHR believes strongly in the importance of educating women about all of the options available to them, including both hormonal and non-hormonal therapies, so they can make informed choices."

The SWHR and Metagenics survey also found that just 23 percent of women ages 50 to 64 said they were aware of all the available therapies for menopause-related hot flashes and only one in five (19 percent) have discussed any and all available options with their healthcare provider.

"For many women, non-hormonal therapies can be a first-line or replacement therapy for reducing menopause-related hot flashes," said Joseph Lamb, MD, Director of Intramural Clinical Research at Metagenics. "I encourage affected women to talk with their healthcare provider to learn more about all available options and determine what may work best for them."

Nurse practitioners are increasingly focused on promoting patient adherence, study finds

As a reorientation towards outcomes takes root in the healthcare industry, NPs are spending more time on patient education and helping their patients stay on medication.

With physicians already in short supply and millions of uninsured Americans set to enter the healthcare system as the Affordable Care Act takes effect, nurses and physician assistants are stepping up to fill the gap. Nurse practitioners (NPs), in particular, are taking a central role in helping patients stay on therapy, according to Manhattan Research's Taking the Pulse Nurses 2013 study.

"Nurse practitioners are playing a key role in driving medication adherence while using a variety of support tools, including digital support and services," said Shawn Dimantha, principal analyst at Manhattan Research.

Promoting adherence to treatment is becoming all the more important to providers and health systems in light of the healthcare reform-fueled shift towards outcomes-based reimbursement. The study, for which Manhattan Research surveyed 909 practicing US nurses and physician assistants, found that:

• Nearly nine out of ten NPs provide patients resources to help them stay on track with their medicines, and three in ten NPs have referred them to digital adherence tools such as websites or apps
• Almost half of NPs said the time they spend on patient education has increased over the past two years
• More than three in five NPs said patient outcomes are a top priority in their practice for the next 1-2 years

"As NPs spend more time on patient education, there is an opportunity for pharma to extend services beyond the pill," said Dimantha, "including providing more engaging online patient education materials and tools that help patients stay on their medication."

Download our State of the Industry: Nurse Practitioners Infographic

This complimentary Infographic looks at how nurse practitioners (NPs) are driving patient education, outcomes, and adherence in and out of the care setting. To access the Infographic, please visit the Infographic page.

Newly-Published Study Concludes Stretta May Be More Desirable GERD Treatment than Chronic PPI Use or Anti-Reflux Surgery in Some Patients

A newly published peer-review study that examines Stretta therapy is bringing renewed attention to this nonsurgical procedure that has 10 years of patient data and recently earned The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) highest GRADE recommendation.

The study, published in Gastroenterology Research and Practice, is titled "Stretta Radiofrequency Treatment for GERD: A Safe and Effective Modality" and presents facts that dispel some misconceptions about Stretta. The study concludes that Stretta is a safe and effective treatment in patients for whom PPI therapy is undesirable, or the many that prefer less invasive treatment options.

Authored by Drs. Mark Franciosa and Hiroshi Mashimo of the Center for Swallowing and Motility Disorders in Boston, VA Boston Healthcare System, and Harvard Medical School, and Dr. George Triadafilopoulos of the Division of Gastroenterology and Hepatology in Stanford University School of Medicine, the study cites experimental and clinical data from a multitude of sources and concludes that Stretta is a valuable nonsurgical treatment option in the management of GERD.

Stretta uses low power and low temperature radiofrequency (RF) energy to remodel the lower esophageal sphincter muscle, thus reducing Gastroesophageal Reflux Disease (GERD) and its symptoms.

"This review of the abundant clinical data, including controlled and randomized studies, as well as studies with long-term follow up, concludes that Stretta is safe, effective, and long-lasting, and a valuable option for many patients seeking relief from their GERD symptoms," stated Dr. Triadafilopoulos. "This is particularly important in light of current concern about long-term PPI use and patient resistance to anti-reflux surgery," stated Dr. Triadafilopoulos.

With the NIH reporting that approximately 20 percent of Americans suffer GERD symptoms at least once a week, doctors are seeking treatment options for GERD. SAGES recently published clinical guidelines (August ‘13 Surgical Endoscopy) that gave Stretta therapy a GRADE recommendation of "++++/strong," citing high quality evidence from 32 clinical trials. Recently presented 10-year post-Stretta data concluded that Stretta is an effective long-term solution for GERD patients.

Dr. Triadafilopoulos pointed to data presented in the study showing Stretta has the longest experience of any non-surgical intervention. "As doctors, we strive to improve the quality of life of patients," Triadafilopoulos stated. "We owe it to GERD sufferers to offer this valuable treatment option."

For more information on Stretta go to stretta-therapy.com.

Researchers Discover a New Pathway in Blood Vessel Inflammation and Disease

Case Western Reserve researchers have identified a genetic factor that blocks the blood vessel inflammation that can lead to heart attacks, strokes and other potentially life-threatening events.

The breakthrough involving Kruppel-like factor (KLF) 15 is the latest in a string of discoveries from the laboratory of professor of medicine Mukesh K. Jain, MD, FAHA, that involves a remarkable genetic family. Kruppel-like factors appear to play prominent roles in everything from cardiac health and obesity to metabolism and childhood muscular dystrophy.

School of Medicine instructor Yuan Lu, MD, a member of Jain's team, led the study involving KLF-15 and its role in inflammation, which appears online this week in the Journal of Clinical Investigation. Lu and colleagues observed that KLF-15 blocks the function of a molecule called NF-kB, a dominant factor responsible for triggering inflammation.

This finding reveals a new understanding of the origins of inflammation in vascular diseases, and may eventually lead to new, targeted treatment options.

"It had been suspected that smooth muscle cells were related to inflammation, but it hadn't been pinpointed and specifically linked to disease," said Jain, Ellery Sedgwick Jr. Chair and director, Case Cardiovascular Research Institute at Case Western Reserve School of Medicine. Jain also is chief research officer for the Harrington Heart & Vascular Institute at University Hospitals Case Medical Center. "This work provides cogent evidence that smooth muscle cells can initiate inflammation and thereby promote the development of vascular disease."

Smooth muscle cells are only one of two major cell types within blood vessels walls. The other cell type, endothelium, has traditionally taken the blame for inflammation, but Jain's study suggests that both cells are critically important in the development of vascular disease.

The researchers learned that expression of this factor appeared mainly in smooth muscle cells and that levels were markedly reduced in atherosclerotic human blood vessels. To establish causality, the team generated genetically-modified mice where they deleted KLF-15 gene in smooth muscle cells.

"We expected to see more proliferation of the smooth muscle cells as this is a common response of this cell type in disease," Lu said, first author on the paper. "Instead, we were surprised to see rampant vascular inflammation and hyper activated NF-kB, the master regulator of inflammation."

The results offer hope for the development of specific anti-inflammatory therapies for vascular disease. Cholesterol-lowering drugs such as statins have some anti-inflammatory effects, but despite their widespread use, the burden of vascular disease remains high. As statins' primary role is to lower cholesterol levels, developing additional or more potent anti-inflammatory therapies are needed to compliment statins' important function.

Jain's previous research of the KLF family of genetic factors revealed regulator functions in blood vessels. KLF4 was shown to potently inhibit inflammation in the endothelium, the other major cell type in vessels. The current work is first to establish a role for these factors in smooth muscle inflammation.

"Collectively, these studies establish KLFs as a central hub regulating vascular health," Jain said. "Boosting levels of these factors may be a particularly effective way to reduce inflammation and the development or progression of vascular diseases such as atherosclerosis."

Cancer Experts Detail New Approaches to Liver Cancer Treatment

Clinical experts outlined promising new approaches to treating liver cancer using radiosurgery with advanced imaging and motion management technology. Presentations on non-invasive radiosurgical approaches to treating hepatocellular carcinoma (HCC) were made by leading clinicians here last week at a meeting organized by the Taiwan Society for Therapeutic Radiology and Oncology and Taiwan Liver Cancer Association.

HCC, the most common type of liver cancer, is globally the third leading cause of cancer mortality after lung and stomach cancer, and a significant problem in Taiwan, mainland China, and other parts of Asia.

"Most patients with HCC are not eligible for surgery or liver transplant," said Theodore Lawrence, MD, PhD, professor and chairman of the Department of Radiation Oncology at the University of Michigan. "Historically we couldn't do much for them with radiotherapy because we lacked the ability to focus the dose on the tumor and minimize exposure of the rest of the liver. That has changed with advanced approaches like stereotactic ablative radiotherapy (SABR)."

Stereotactic ablative radiotherapy (SABR) is a type of radiosurgery that involves the careful use of modern technologies for 3-D image guidance, motion management, and beam shaping. Dr. Lawrence and his clinical team customize their use of SABR for each patient according to a predictive model they have developed based on treatment data from over 400 HCC cases. This model helps them determine the optimal radiation dose to use given the volume of liver to be treated. "High doses can be given safely if enough normal liver can be spared," he explained.

Single-Dose Image-Guided Treatments

Carlo Greco, MD, professor and director of clinical research at the Champalimaud Foundation in Lisbon, Portugal, discussed advances in imaging and biological targeting that enable high precision single-dose image-guided radiotherapy (SD-IGRT) for treating metastatic lesions in the liver as well as elsewhere in the body. "These treatments depend on our ability to accurately position patients for treatment, use imaging for precise targeting, and manage motion during treatment," said Dr. Greco.

The TrueBeam platform from Varian Medical Systems, with its high dose delivery rate, enables fast completion of these otherwise time-consuming treatments. "Since we installed the TrueBeam machine in early 2012, we have treated over 400 metastatic lesions with high dose SD-IGRT," Dr. Greco said. "Lung, bone, liver, adrenal gland and lymph node lesions have been the focus of our experience. Based on follow-up imaging studies, we're seeing outstanding early local control rates, with 95 percent of lesions free of relapse at twelve months following treatment."

Encouraging Outcomes Reported From Milan

Marta Scorsetti, MD, director of the Department of Radiation Oncology and Radiosurgery at the Humanitas Cancer Center in Milan, Italy, presented her work evaluating the feasibility and efficacy of SABR in the treatment of both inoperable primary liver cancer and liver metastases. She reported on the results obtained with 67 patients treated for metastatic lesions, and 18 patients with primary HCC lesions.

While specific local tumor control and overall survival results varied, after a median follow-up of 12 months all groups showed acceptable rates of local tumor control and very little treatment related toxicity. No radiation induced liver disease (RILD) was detected, Dr. Scorsetti reported.

Gated RapidArc for Treating Liver Cancer

Po-Ming Wang, MD, chief radiation oncologist at Cheng Ching General Hospital in Taichung, Taiwan, summarized his experience using Varian's TrueBeam STx system to deliver gated RapidArc radiosurgery in the treatment of liver cancer. RapidArc speeds up highly precise radiosurgery treatments by constantly shaping and reshaping the treatment beam to match the shape of the tumor while delivering dose continuously as the treatment machine rotates around the patient. Gated RapidArc makes it possible to monitor patient breathing and compensate for tumor motion during a RapidArc treatment.

"With the TrueBeam STx, we are able to image the tumor during the treatment and adapt the treatment delivery in 'real time' based on observable changes," said Dr. Wang. "This helps us to better target the liver tumor and minimize the impact on surrounding critical organs like the duodenum or stomach. The gated RapidArc technique also helps to preserve more of the patient's normal liver volume."

"Varian was pleased to provide financial support for this important meeting, which was the first liver-specific SABR meeting to take place in the Asia Pacific region," said Clif Ling, PhD, director of advanced clinical research for Varian. "The meeting was attended by radiation oncology and hepatology professionals and designed to provide a platform for liver cancer experts in Taiwan to begin to form a consensus about how to use SABR—a relatively new capability in radiation oncology—to treat HCC. We hope that better understanding of the use of SABR for HCC will lead to improved treatment results."